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Evaluation of b-Caryophyllene in osteoarthritis patients

Formulation and clinical evaluation (Phase 2 clinical trial) of complementary therapy with b-Caryophyllene in osteoarthritis patients: determination of effectiveness and safety

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180103038199N9
Enrollment
120
Registered
2021-12-05
Start date
2026-02-20
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of knee. Osteoarthritis of knee

Interventions

Intervention 1: Intervention group: Patients with primary osteoarthritis receive a 30 mg soft capsule of b-caryophyllene made by Mashhad University of Medical Sciences. Patients take this soft capsule

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: Lack of proper response (having a score higher than 30 on the VAS numerical-visual scale at the beginning of the study) to the analgesic drug meloxicam after at least two weeks of drug administration before the start of the study Age between 40-70 years old Patients with BMI lower than 37

Exclusion criteria

Exclusion criteria: Patient's dissatisfaction with continued cooperation during the study Need to perform any new therapeutic interventions during the study period Active liver or kidney disease and malignancies Secondary or suspected osteoarthritis Patients treated with hormonal medicines Patients treated with anticoagulants Patients with a history of ischemic or hemorrhagic stroke Patients with a history of deep vein thrombosis Treatment with oral corticosteroids 4 weeks before the start of the study Intra-articular injection of hyaluronic acid three months before the start of the study Pregnancy Patients who have had intra-articular corticosteroid injections in the last 4 weeks

Design outcomes

Primary

MeasureTime frame
Clinical indicators of osteoarthritis. Timepoint: At the beginning of the study and every week until the eighth week. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) standardized questionnaire.

Secondary

MeasureTime frame
Complete Blood Cell Count with Differential. Timepoint: At the beginning and the end of the study. Method of measurement: Using an auto-analyzer system.;Interleukin-4 level. Timepoint: At the end of the study. Method of measurement: Using a laboratory kit.;Interferon-gamma level. Timepoint: At the end of the study. Method of measurement: Using a laboratory kit.;Interleukin-10 level. Timepoint: At the end of the study. Method of measurement: Using a laboratory kit.;High-sensitivity C-reactive protein (hs-CRP) level. Timepoint: At the beginning and the end of the study. Method of measurement: Using a laboratory kit.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactVahid Reza Askari

Mashhad University of Medical Sciences

askariv@mums.ac.ir+98 51 3800 2264

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026